The Committee for Medicinal Products for Human Use
recommended granting marketing authorization for Entyvio for
adults who didn’t respond to or couldn’t tolerate other
treatments, the London-based regulator said today in a
statement. The European Commission usually follows the panel’s
advice.

The treatment, also known as vedolizumab, is being reviewed
by the U.S. Food and Drug Administration for both indications. A
decision on its use in ulcerative colitis is expected by May 20
and for Crohn’s disease by June 18. An advisory panel
recommended the drug be approved for both illnesses even after
FDA staff raised concerns about the risk of a deadly brain
infection.

Among patients with ulcerative colitis who took Takeda’s
intravenous drip vedolizumab for a year, at least 40 percent had
a temporary end to symptoms compared with those who took placebo
for the same period, according to a study published last year in
the New England Journal of Medicine. A separate study found the
drug helped Crohn’s patients reach remission after a year of
treatment, compared with those on placebo.

Inflammatory bowel diseases are chronic with no cure and
are more common in industrialized countries though there is
thought to be a strong genetic link, according to the Centers
for Disease Control and Prevention.